{"id":2361,"date":"2010-03-26T10:32:09","date_gmt":"2010-03-26T18:32:09","guid":{"rendered":"http:\/\/hodakvalue.com\/blog\/?p=2361"},"modified":"2010-03-29T05:55:30","modified_gmt":"2010-03-29T13:55:30","slug":"government-run-health-care-we-cant-be-bothered","status":"publish","type":"post","link":"http:\/\/hodakvalue.com\/blog\/government-run-health-care-we-cant-be-bothered\/","title":{"rendered":"Government-run health care: A glimpse of the future"},"content":{"rendered":"

Boston Scientific, maker of those ultra-cool, implantable defibrillators, made some minor changes to the way they manufactured them.\u00a0 There was nothing wrong with the devices under the old manufacturing method–they just felt that they could do better.\u00a0 Unfortunately, the company ran afoul of the bewilderingly complex FDA documentation rules that require any manufacturing changes to be reported to them.\u00a0 As a result, Boston Scientific has been forced to recall a bunch of perfectly good, life-saving devices<\/a>, and submit their manufacturing changes for FDA review before being allowed to resume manufacturing.\u00a0 FDA review times run from 8 to 30 days.<\/p>\n

Boston-Scientific tried to calm their medical customers (and investors) by hinting that the urgency of this matter should warrant a shorter review period.\u00a0 During this period, doctors are doing without the device (“Hang in there Charlie!\u00a0 We’ll get that thing implanted in the next few weeks.”), and Boston-Scientific is losing $5 million a day.\u00a0 If ever we needed those high-priced government services<\/a>, this would be it, right?<\/p>\n

FDA officials said in an interview that they have given Boston Scientific’s applications a preliminary look and the submissions appear to be in order.\u00a0 But the officials said the agency hasn’t begun an in-depth review of the material and the company will have to wait its turn.<\/em><\/p>\n

Boston Scientific’s filings are “in the queue, and we’re going to take it when it comes up,” said Gladys Rodriguez, an enforcement director at the FDA’s Center for Devices and Radiological Health who is involved in the review.\u00a0 “At this point, we’re not expediting.”\u00a0 The FDA has 30 days to do a review, Ms. Rodriguez said.<\/em><\/p><\/blockquote>\n

Translation from bureaucrat lingo: “We can’t be bothered.”\u00a0 I mean, c’mon, it’s not like its their<\/em> lives or money on the line.<\/p>\n","protected":false},"excerpt":{"rendered":"

Boston Scientific, maker of those ultra-cool, implantable defibrillators, made some minor changes to the way they manufactured them.\u00a0 There was nothing wrong with the devices under the old manufacturing method–they just felt that they could do better.\u00a0 Unfortunately, the company ran afoul of the bewilderingly complex FDA documentation rules that require any manufacturing changes to […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[72],"tags":[73],"class_list":["post-2361","post","type-post","status-publish","format-standard","hentry","category-government-service","tag-ugh-another-day-of-reviews"],"_links":{"self":[{"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/posts\/2361","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/comments?post=2361"}],"version-history":[{"count":12,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/posts\/2361\/revisions"}],"predecessor-version":[{"id":2386,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/posts\/2361\/revisions\/2386"}],"wp:attachment":[{"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/media?parent=2361"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/categories?post=2361"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/hodakvalue.com\/blog\/wp-json\/wp\/v2\/tags?post=2361"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}